Trial record 2 of 48 for:    PEARL II

Registry of AngioJet Use in the Peripheral Vascular System (PEARLII)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by MEDRAD, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
MEDRAD, Inc.
ClinicalTrials.gov Identifier:
NCT01086215
First received: January 20, 2010
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

The Registry involves the collection of information for research and educational purposes only on the use of AngioJet in the peripheral vascular system.


Condition
Peripheral Vascular Disease
Embolism and Thrombosis
Venous Thrombosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PEARL II: PEripheral Use of AngioJet® Rheolytic Thrombectomy With a Variety of Catheter Lengths

Resource links provided by NLM:


Further study details as provided by MEDRAD, Inc.:

Primary Outcome Measures:
  • To estimate the rate of AngioJet® System related adverse events. [ Time Frame: Day 1, 3 Month , 6 Month and 12 Month Follow Ups ] [ Designated as safety issue: Yes ]
  • To estimate the change in degree of occlusion from Baseline to Final angiogram. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • To estimate the proportion of successful patients post-procedure and those affected by restenosis and /or rethrombosis of the treated vessels throughout a 12 Month Follow-Up. [ Time Frame: Day 1, 3 Month , 6 Month and 12 Month Follow Ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize treatment options used concomitantly with the AngioJet® System for occlusions occurring in the peripheral vascular system. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • To characterize the occurrence of clinical events. [ Time Frame: Day 1, 3 Month , 6 Month and 12 Month Follow Ups ] [ Designated as safety issue: Yes ]
  • To estimate the proportion of limb ischemia patients in whom the limb was salvaged. [ Time Frame: Day 1, 3 Month , 6 Month and 12 Month Follow Ups ] [ Designated as safety issue: No ]
  • To assess the quality of life at Baseline and throughout a 12 Month Follow-Up. [ Time Frame: Day 1, 3 Month , 6 Month and 12 Month Follow Ups ] [ Designated as safety issue: No ]
  • To estimate the compressibility and valve closure time in lower extremity DVT patients. [ Time Frame: Day 1, 3 Month , 6 Month and 12 Month Follow Ups ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Limb Ischemia
Patients presenting with limb ischemia for treatment
Deep Vein Thrombosis
Patients presenting with deep vein thrombosis for treatment
Hemodialysis Access
Patients presenting with thrombosed hemodialysis access for treatment
Other Thrombotic Conditions
Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment

Detailed Description:

The PEARL II Registry is a prospective, multi-center, observational registry including 500 patients who meet eligibility from up to 50 sites worldwide. Patient participation will be 12 months including post procedure follow-up contact at 3, 6 and 12 months. The study duration is estimated at 36 months.

A patient's treatment is determined by the treating physician based on the clinical situation and local practices. In contrast to a randomized, controlled trial, there are no pre-defined experimental interventions.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community population

Criteria

Inclusion Criteria:

  • Patient has been treated in the peripheral vascular system with any of the AngioJet System catheters.
  • Patient has provided appropriate consent/authorization per the site's institutional policy and procedure.

Exclusion Criteria:

  • Patient has previously been enrolled in either the PEARL Registry or the PEARL II Registry in the last 12months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086215

  Hide Study Locations
Locations
United States, Arizona
Phoenix Heart, PLLC
Glendale, Arizona, United States, 85306
John C. Lincoln Deer Valley Hospital
Phoenix, Arizona, United States, 85029
United States, California
Good Samaritan Hospital
Los Angeles, California, United States, 90017
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19718
United States, Florida
University of Florida- College of Medicine
Jacksonville, Florida, United States, 32209
First Coast Cardiovascular Institute
Jacksonville, Florida, United States, 32216
Sacred Heart Hospital
Pensacola, Florida, United States, 32504
United States, Georgia
Chris Recknor PC
Gainesville, Georgia, United States, 30501
United States, Indiana
Indiana University Health Arnett
Lafayette, Indiana, United States, 47905
United States, Iowa
Iowa Health
Des Moines, Iowa, United States, 50263
United States, Louisiana
Cardiovascular Consultants
Bossier City, Louisiana, United States, 71111
Terrebonne General Medical Center
Houma, Louisiana, United States, 70360
Regional Medical Center of Acadiana
Lafayette, Louisiana, United States, 70506
United States, New Jersey
Chilton Memorial Hospital
Pompton Plains, New Jersey, United States, 07444
United States, New York
Mount Sinai School of Medicine
New York City, New York, United States, 10029
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Grant Medical Center
Columbus, Ohio, United States, 43215
Good Samaritan Hospital
Dayton, Ohio, United States, 45435
The University of Toledo Medical Center
Toledo, Ohio, United States, 43614
United States, Pennsylvania
St Luke's Hospital & Health Network
Bethlehem, Pennsylvania, United States, 18015
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
The Reading Hospital & Medical Center
Reading, Pennsylvania, United States, 19611
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
University of South Carolina
Charleston, South Carolina, United States, 29401
United States, South Dakota
North Central Heart Institute
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Holston Valley Medical Center
Kingsport, Tennessee, United States, 37660
University of Tennessee - Knoxville
Knoxville, Tennessee, United States, 37920
United States, Virginia
Winchester Medical Center
Winchester, Virginia, United States, 22601
United States, West Virginia
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Canada, Manitoba
Winnipeg Regional Health Authority
Winnipeg, Manitoba, Canada, R3A 1R9
Germany
Städtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Germany
Italy
University of Naples
Naples, Italy
Slovakia
National Institute of CV Diseases
Bratislava, Slovakia
Sponsors and Collaborators
MEDRAD, Inc.
Investigators
Principal Investigator: Lawrence Blitz, MD Chilton Memorial Hospital
Study Director: Robert Lookstein, MD Mount Sinai School of Medicine
Principal Investigator: Ali Amin, MD The Reading Hospital & Medical Center
  More Information

No publications provided

Responsible Party: MEDRAD, Inc.
ClinicalTrials.gov Identifier: NCT01086215     History of Changes
Other Study ID Numbers: PEARLII
Study First Received: January 20, 2010
Last Updated: July 9, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vascular Diseases
Thrombosis
Peripheral Vascular Diseases
Peripheral Arterial Disease
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Thromboembolism

ClinicalTrials.gov processed this record on September 16, 2014